Background

Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first hip resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant.

The purpose of this study was to compare the clinical, radiographic, and DEXA results of Epoch® Femoral Component for primary THA with other non-cemented femoral components. The Epoch and Epoch 14+ (Zimmer, Warsaw, IN) Composite Femoral Components were studied in conjunction with the VerSys® Fiber Metal Taper, Fiber Metal Mid coat and Beaded Fullcoat Femoral Components (Zimmer, Warsaw, IN). All patients were randomized into one of five component groups and followed prospectively. All patients across the five groups were matched with respect to demographics and body mass index (BMI) (Table 1). Diagnoses were evenly distributed across all study groups. There was no significant change in BMD at 5-years when compared to the baseline (6 month) DEXA measurements for all component groups except for the Beaded Fullcoat component subset which had significant decreases in BMD in proximal zones 1, 6 and 7, The Fiber Metal Taper showed similar decreases in BMD in zones 1 and 7, and the Epoch Component had a significant decrease in BMD in zone 7 only. Additionally, our DEXA findings complement and support the subjective radiographic interpretations performed for this study cohort. The results from this prospective, randomized controlled clinical trial showed that the Epoch Composite Femoral Component for primary THA can achieve results equal to standard alloy components of varying design. Based on these early results, the Epoch and Epoch 14+ Femoral Components for primary THA are justified for continuance of further prospective study.